510(k) Report

Devices descending from K150239

25 later devices reach FibroScan through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181547FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)Echosens201814—
+1K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+2K203273FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)Echosens20219—
+2K200655FibroScan® 630Echosens20200—
+2K200136Shear Wave Quantificational Ultrasound Diagnostic SystemWuxi Hisky Medical Technologies Co., Ltd.20202—
+2K1732916440 Ultrasound SystemEsaote, S.p.A.20188—
+3K250026Shear Wave Quantificational Ultrasound Diagnostic System…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+3K243880Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+3K2301796440 MyLabX90Esaote, S.p.A.202341
+3K223902FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)Echosens20231—
+3K213102ES1 SystemE-Scopics20223—
+3K212035FibroScan 230Echosens20215—
+3K1921576450 Ultrasound systemEsaote, S.p.A.20194—
+3K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+4K260748ES-SeriesE-Scopics20260—
+4K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)Esaote, S.p.A.20252—
+4K2416716450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20252—
+4K233401Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile)Eieling Technology Limited20242—
+4K232336ES Series V2E-Scopics20232—
+4K2120216430 MyLabX75, 6430 MyLab XPro75Esaote, S.p.A.20210—
+5K260589ES-SeriesE-Scopics20260—
+5K2532886450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20260—
+5K253221Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)Eieling Technology (Shenzhen) Limited20260—
+5K2533107600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)Esaote, S.p.A.20250—
+5K242496Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C)Eieling Technology (Shenzhen) Limited20240—